NCT06399471

Personalizing MPK Prescription

Personalizing MPK Prescription for Individuals With Transfemoral Amputation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Georgia Institute of Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In current clinical prosthetic practice, there is no evidence based method for selecting a microprocessor knee (MPK) joint for a patient with an above the knee amputation. Of individuals with amputation in veteran and service member populations, approximately 35% present with an above the knee amputation. It is well understood in clinical practice that MPKs provide numerous benefits to patients with amputations above the knee including improved gait, safety, comfort, confidence, reduced falls, balance, patient satisfaction and reduced energy expenditure, greater ease in negotiating varying terrains, improvements in multi-tasking and cost effectiveness. Studies that have investigated commercially available MPKs tend to lump all of them together within a single group rather than teasing out individual differences between each knee. Therefore, clinicians are left to rely on their own intuition and past experiences with an MPK when selecting for a patient with an above the knee amputation rather than making their decision based on evidence collected from the specific patient. This may mean that some individuals with an above the knee amputation may not be receiving the best component for them which may delay or inhibit their rehabilitation potential following their amputation.

Conditions

• Transfemoral Amputation

Interventions

Type	Name	Description
DEVICE	Microprocessor prosthetic knee	Microprocessor prosthetic knees for use in a transfemoral prosthesis

Timeline

• Start date: 2021-10-25
• Primary completion: 2023-10-02
• Completion: 2023-10-02
• First posted: 2024-05-03
• Last updated: 2024-11-14
• Results posted: 2024-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study